HPLC法测定左羟丙哌嗪片血药浓度

Determination of concentration of levodropropizine in plasma by RP-HPLC with fluorescence detector

目的建立HPLC-荧光法测定人血浆中左羟丙哌嗪浓度,用于生物利用度及药物动力学研究.方法血样经液-液萃取后,用HiQsil C18(150.0 mm×4.6mm,5μm)柱,柱温30℃,以0.1 M磷酸二氢钾(磷酸调pH值至2.51):乙腈:甲醇(82:3:15)为流动相,流速0.6mLmin,检测波长:Ex=240nm,Em=350nm进行分离.结果血浆中杂质不干扰样品测定,在3.46～886 ng/mL范围线性良好,最低可定量浓度为3.46 ng/mL(信噪比＞3),萃取回收率大于80.00%,方法回收率在106.12%～109.05%,日内和日间RSD均小于10.00%.结论该法灵敏、准确,适合左羟丙哌嗪血药浓度监测.

[Objective] To establish a RP-HPLC method for determining levodropizine. [Method] Levodropizine was extracted from blood samples. Determination of levodropizine were carried out using a HiQsil C18 (150×4.6 mm, 5 μm) column at 30℃. the mobile phase consisted of 0.1M KH2PO4:acetonitrile:methanol (82:3:15). The flow rate was 0.6ml.min-1.The wave length of fluorescence determination: Ex=240 nm, Em=350 nm. [Result] Levodropizine could be separated well. The calibration curves of levodropizine in the range of 3.46~886 ng/mL were linear. The minimal quantified concentration of levodropizine was 3.46 ng/mL. The relative recovery were 106.12%~109.05%. The absolute recovery of levodropizine from plasma were more than 80%. The RSD of inter-day and intra-day were less than 10.0%. [Conclusion] The method is accurate and sensitive. It is suitable to be applied in thetheraputic drug monitor of levodropizine.